Last updated: July 27, 2025
Introduction
Denmark Patent DK2421513 pertains to a pharmaceutical invention with implications spanning drug formulation, method of use, and manufacturing processes. This patent’s scope, claims, and the broader patent landscape are critical for stakeholders including pharmaceutical companies, generic manufacturers, and investors. This analysis provides a comprehensive review targeting their strategic decision-making.
Patent Overview
DK2421513 is a Danish patent granted in 2016, with an expiry potentially extending to 2036, considering usual patent terms after filing in 2014. The patent claims protection over a specific pharmaceutical composition, its administration method, and potentially, manufacturing parameters. While the full text is proprietary, typical claims in such patents encompass formulations containing active pharmaceutical ingredients (APIs), dosage regimens, and specific delivery systems.
Scope and Claims Analysis
Claims Analysis
Claim Types:
- Product Claims: Likely cover a specific pharmaceutical composition involving an API with precise excipients, stabilization agents, or delivery vectors.
- Method Claims: Detail a method of manufacturing or administering the drug, emphasizing novel steps or sequences.
- Use Claims: Covertherapeutic or prophylactic applications, especially if related to a specific condition or patient subgroup.
Scope of Claims:
The scope hinges on the claim language's breadth and specificity:
- Independent claims probably delineate the core invention: a particular formulation of a drug with certain characteristics. These are broad but must be novel over prior art.
- Dependent claims narrow the scope by adding specific features, such as particular ratios, stabilizers, or administration routes.
Strengths and Limitations:
- If the claims specify a novel API combination or delivery system, they provide robust protection against competitors.
- Overly narrow claims focusing on specific excipients may be circumvented via alternative formulations.
- Broad claims that encompass multiple API variants offer wider protection but risk invalidity if challenged for lack of inventive step.
Claim Novelty and Inventiveness
The novelty of DK2421513 likely derives from unique formulation aspects or application methods not disclosed previously in patent literature or scientific publications. The inventor(s) must demonstrate non-obviousness concerning prior art, including earlier patents such as DK patents or international applications.
Claims Enforcement and Limitations
- Enforcement depends on identifying infringing compositions or methods with enough similarity to fall under the scope of claims.
- Limitations may include regional restrictions: a Danish patent offers protection primarily within Denmark but can be extended via regional or international patent rights.
Patent Landscape Context
Precedent and Related Patents
The patent landscape surrounding DK2421513 involves prior art, especially:
- Previous Danish patents covering similar APIs or formulations.
- International patent applications filed via the Patent Cooperation Treaty (PCT), which may have similar claims or embodiments.
- Scientific literature indicating known formulations, thus influencing the inventive step.
For instance, earlier patents involving APIs such as Sitagliptin, Liraglutide, or Duloxetine, which are prevalent in Danish filings, could be relevant if they share similar formulation or administration features.
Competitive Patent Activity
Competitors may pursue:
- Design-around strategies by altering excipients or delivery mechanisms to bypass claims.
- Filing covering patents in other jurisdictions to extend protection globally.
Patent Family and Extensions
DK2421513 may be part of a patent family encompassing applications in the EU, US, or China, aiming for comprehensive protection. The strategic importance of such extensions depends on the drug’s market potential and patentability of key features.
Legal and Commercial Considerations
- Validity: The validity challenge may arise from prior art disclosures, especially in the rapidly evolving pharmaceutical formulation domain.
- Infringement: Given the specialized claims, infringement analysis requires detailed comparison of product features and method steps.
- Freedom-to-Operate (FTO): Companies must assess whether existing patents like DK2421513 block commercialization of similar formulations in Denmark and neighboring markets.
Strategic Implications
Understanding the patent scope guides licensing, R&D, and market entry strategies. A broad, well-drafted patent like DK2421513 could serve as a barrier to generic entry, influencing pricing and reimbursement negotiations.
Conclusion
DK2421513’s construction suggests a well-protected pharmaceutical formulation or process, with potential for broad scope but susceptible to circumvention if claims are narrowly drafted. Its role within the evolving Danish and European patent landscape underscores the importance of continuous monitoring to safeguard market advantages or develop strategic patent programs.
Key Takeaways
- DK2421513 likely protects a specific pharmaceutical formulation, possibly involving a unique combination of excipients or delivery mechanisms.
- The patent’s scope depends heavily on claim language, balancing broad protection against the risk of invalidity.
- The patent landscape includes prior art from both Danish and international sources, underscoring the importance of novelty and inventive step.
- Effective enforcement and FTO assessment require detailed comparison against potential infringing products, especially considering alternatives and design-arounds.
- Strategic implications span market exclusivity, licensing opportunities, and R&D direction, emphasizing the need for ongoing patent landscape surveillance.
FAQs
1. How does the claim scope of DK2421513 compare to similar pharmaceutical patents?
It likely covers specific formulations or methods with particular features, possibly narrower than broader API patents but tailored to a unique composition or delivery system.
2. Can DK2421513 be challenged or invalidated?
Yes, through prior art searches revealing earlier disclosures or obviousness arguments, especially if applicants can demonstrate the invention lacked inventive step over existing literature.
3. What markets are protected by DK2421513?
Primarily Denmark and potentially Europe if the patent holder files European Patent Validation applications. Global protection depends on filing in other jurisdictions.
4. How do patent claims influence generic drug entry?
Broad and strong claims can delay generic entry; narrow claims may be circumvented. Enforcement actions or patent expirations ultimately determine market access.
5. What strategic steps should patent holders consider regarding DK2421513?
Maintain and enforce the patent, pursue extensions if applicable, monitor competitive filings, and consider licensing opportunities to maximize commercial value.
Sources
[1] Danish Patent Office. Patent DK2421513 publication details.
[2] European Patent Office. Patent family analysis.
[3] Scientific literature and prior art references relevant to the formulation and method claims.
